The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1690-2020·Announced 2020-04-15

Microbiologics Recalls KWIK-STIK Trichosporon Dermatis Culture Pack

Microbiologics Inc is recalling KWIK-STIK 2 Pack Trichosporon dermatis cultures because they may contain Candida utilis instead of the labeled organism.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where the product may contain a different organism than labeled. No illnesses or injuries are reported, and the hazard is limited to potential misidentification in a laboratory setting.

Plain-English summary

Microbiologics Inc is recalling 49 units of KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3). The recall is due to a labeling error where the product may contain Candida utilis instead of the labeled Trichosporon dermatis.

The affected products were distributed nationwide and internationally, including in Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, the United States, and Uruguay. The recall also involves the KWIKSTIK YST Comprehensive QC Set (REF 5195P).

Users should stop using the affected products and contact Microbiologics Inc for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product
KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Manufacturer
Microbiologics Inc
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
49

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Catalog Number: 0778P. Lot Number: 778-65-3. UDI 20845357018773.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Microbiologics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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